Free GAQM ISO-QMS-13485 Exam Questions
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GAQM ISO-QMS-13485 Exam Questions
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Provided By: GAQM
- Exam: ISO 13485:2016 - Certified Lead Auditor
- Certification: GAQM ISO
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Total Questions: 300
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Updated On: Apr 28, 2025
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Rated: 4.9 |
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Online Users: 600
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Question 1
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A medical device company uses a commercial off-the-shelf (COTS) software program for managing its training records. The software is not directly used in the manufacturing process but is integral to personnel training and demonstrating compliance with ISO 13485:2016. The Lead Auditor reviews the company's training procedure and notes the procedure indicates the company must perform testing of software used within the QMS, and validation is not required. Which of the following would be the MOST appropriate determination for the Lead Auditor?
Answer: D
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A medical device company uses a commercial off-the-shelf (COTS) software program for managing its training records. The software is not directly used in the manufacturing process but is integral to personnel training and demonstrating compliance with ISO 13485:2016. The Lead Auditor reviews the company's training procedure and notes the procedure indicates the company must perform testing of software used within the QMS, and validation is not required. Which of the following would be the MOST appropriate determination for the Lead Auditor?
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Question 2
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A medical device company is undergoing an ISO 13485:2016 audit. The Lead Auditor observes that the company uses a software program to manage customer complaints and track corrective actions. The software program allows users to easily generate reports and analyze trends in customer feedback. The manufacturer has performed initial validation and has documented a process for regular preventative maintenance of the software. What additional action must be verified by the Lead Auditor to ensure compliance?
Answer: A
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A medical device company is undergoing an ISO 13485:2016 audit. The Lead Auditor observes that the company uses a software program to manage customer complaints and track corrective actions. The software program allows users to easily generate reports and analyze trends in customer feedback. The manufacturer has performed initial validation and has documented a process for regular preventative maintenance of the software. What additional action must be verified by the Lead Auditor to ensure compliance?
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Question 3
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A medical device company is undergoing an ISO 13485:2016 audit. The company uses a contract manufacturer for a critical component of their Class II medical device. The Lead Auditor reviews the company's **documented procedure**, or lack thereof, for controlling the outsourced process. The quality agreement with the contract manufacturer clearly defines the product specifications, quality requirements, and acceptance criteria. The medical device company performs a thorough risk assessment of any changes notified to them. There is evidence of recent performance data trending showing sustained compliance, however, the quality agreement does not define how frequently the quality agreement itself is reviewed or updated. As a Lead Auditor, what is the MOST appropriate determination regarding the company's approach?
Answer: D
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A medical device company is undergoing an ISO 13485:2016 audit. The company uses a contract manufacturer for a critical component of their Class II medical device. The Lead Auditor reviews the company's **documented procedure**, or lack thereof, for controlling the outsourced process. The quality agreement with the contract manufacturer clearly defines the product specifications, quality requirements, and acceptance criteria. The medical device company performs a thorough risk assessment of any changes notified to them. There is evidence of recent performance data trending showing sustained compliance, however, the quality agreement does not define how frequently the quality agreement itself is reviewed or updated. As a Lead Auditor, what is the MOST appropriate determination regarding the company's approach?
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Question 4
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A medical device company uses a contract manufacturer to produce a critical component for one of their Class III devices. During an ISO 13485:2016 audit of the medical device company (not the contract manufacturer), the Lead Auditor reviews the records pertaining to the oversight of the contract manufacturer. The records show regular communication, agreed-upon specifications, and documented inspections of incoming components. However, there is no documented evidence of periodic on-site audits of the contract manufacturer's facilities. What is the MOST appropriate conclusion for the Lead Auditor to draw?
Answer: C
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A medical device company uses a contract manufacturer to produce a critical component for one of their Class III devices. During an ISO 13485:2016 audit of the medical device company (not the contract manufacturer), the Lead Auditor reviews the records pertaining to the oversight of the contract manufacturer. The records show regular communication, agreed-upon specifications, and documented inspections of incoming components. However, there is no documented evidence of periodic on-site audits of the contract manufacturer's facilities. What is the MOST appropriate conclusion for the Lead Auditor to draw?
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Question 5
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During an ISO 13485:2016 audit, the Lead Auditor discovers that a medical device company uses a cloud-based software to manage its training records. The software provider states the system is fully compliant with all relevant data privacy requirements such as GDPR and HIPAA. The manufacturer performs an annual review of the software provider’s SOC 2 Type II report to verify its compliance with relevant security standards. Considering the requirements of ISO 13485:2016 regarding the control of outsourced processes, what should be your MOST appropriate next action?
Answer: B
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During an ISO 13485:2016 audit, the Lead Auditor discovers that a medical device company uses a cloud-based software to manage its training records. The software provider states the system is fully compliant with all relevant data privacy requirements such as GDPR and HIPAA. The manufacturer performs an annual review of the software provider’s SOC 2 Type II report to verify its compliance with relevant security standards. Considering the requirements of ISO 13485:2016 regarding the control of outsourced processes, what should be your MOST appropriate next action?